drugset / Trial / NCT07411950
EuroPainClinicsStudy IX ( EPCS IX )
Completed
141 enrolled
EPC Education s.r.o.
East Slovak Institute for Cardiovascular Diseases · collabSlovak Academy of Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without prior lumbar surgery. Epiduroscopy allows direct visualization of the epidural space with targeted mechanical adhesiolysis and optional epidural pharmacologic treatment. The primary objective is to evaluate pain relief and functional improvement following the procedure. Secondary outcomes include disability scores, quality of life, and procedure-related complications. The study aims to determine whether prior lumbar surgery influences clinical outcomes after epiduroscopic treatment.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2025-05-31
- Completion
- 2025-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hypertonic saline | Unknown | 10 ml | Other |
| Subject | Methylprednisolone | Other / unclassified | 40 mg | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 1500 iu | Other |